SMT Supraflex Cruz DES for HBR Patients Evaluated in COMPARE RCT

October 16, 2024—Sahajanand Medical Technologies (SMT) announced results of the COMPARE 60/80 HBR trial evaluating the company’s Supraflex Cruz stent in high-bleeding-risk (HBR) patients.

Pieter C. Smits, MD, with Maasstad Hospital in Rotterdam, the Netherlands, is Principal Investigator of the trial, and the study findings were published by Dr. Smits et al in Circulation: Cardiovascular Interventions.

The COMPARE 60/80 HBR randomized controlled trial (RCT) compared performance of the biodegradable-polymer, sirolimus-eluting 60-µm Supraflex Cruz stent versus the biodegradable-polymer 80-µm Ultimaster Tansei stent (Terumo Interventional Systems) in percutaneous coronary intervention (PCI) patients with HBR undergoing abbreviated dual antiplatelet therapy (DAPT).

According to the company, the study was conducted at 11 centers in the Netherlands and enrolled 741 patients at high risk of both bleeding and ischemia.

Only patients with HBR as defined by the criteria of the Academic Research Consortium (ARC) for HBR guidelines were enrolled, stated the company.

SMT reported that the trial demonstrated noninferiority of the Supraflex Cruz stent compared to the Ultimaster Tansei stent in terms of net adverse clinical events at 12 months, with rates of 15.4% versus 17. 1% (P = .02 for noninferiority).

The Supraflex Cruz stent showed a significant reduction in clinically driven target lesion revascularization rates and very low rates of stent thrombosis, despite the fact that enrolled patients were at substantial risk for bleeding and ischemic events, stated SMT.

“In this RCT in a high-risk group, the first head-to-head comparison in patients with the new ARC definition of HBR, Supraflex Cruz demonstrated excellent clinical outcomes, with noninferiority to the Ultimaster Tansei stent,” commented Dr. Smits in SMT’s press release.

Dr. Smits continued, “As DAPT durations have progressively decreased after PCI, the need for safe and effective DES has become even more important. In this context, Supraflex Cruz provides an excellent choice for physicians with its proven safety and potentially better outcomes for our patients, even in the setting of short DAPT.”

Krishna Sudhir, MD, Chief Medical Officer at SMT, stated, “In one more European RCT, Supraflex Cruz has demonstrated outstanding performance, with low clinical event rates in a very high-risk subset of patients. This study extends findings from the TALENT and FIRE randomized trials, confirming an excellent efficacy and safety profile for the Supraflex Cruz stent in patients with coronary artery disease at high risk of bleeding.”